HypercholesterolaemiaPhase 2NCT07610278
A Study to Evaluate the Pharmacodynamics of a Combination of QCZ484 and Inclisiran in Participants With Hypertension and Concomitant Hypercholesterolemia
A Phase 2 study testing QCZ484 and Inclisiran in people with Hypercholesterolaemia, run by Novartis Pharmaceuticals at 29 sites in United States.
Trial summary
This is a multicenter, randomized, double-blind, factorial design Phase 2 study to evaluate the pharmacodynamics, safety and tolerability of a combination of QCZ484 and inclisiran compared to QCZ484, inclisiran, and placebo in participants with hypertension and concomitant hypercholesterolemia. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypercholesterolaemia
- What is being tested?
- QCZ484 and Inclisiran
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 29 sitesUnited States
- Study dates
- 29 May 2026to 3 Feb 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females aged 18 to 75 years.
- Diagnosis of primary hypertension.
- Treatment with either no, or up to 2 antihypertensive medications at a stable dose for at least 4 weeks preceding screening.
- Systolic blood pressure ≥140 and <165 mmHg based on the mean of 3 sitting measurements based on office blood pressure monitoring.
- Diagnosis of hypercholesterolemia including heterozygous familial hypercholesterolemia unable to reach LDL-C goals with a stable dose of statin treatment for at least 4 weeks prior to screening as per Investigator judgement, guidelines and local practice (if tolerated and not contraindicated) with or without bempedoic acid and with or without ezetimibe prescribed according to local guidance, at a stable dose for at least 4 weeks preceding Screening Visit 1.
- The following parameters must be confirmed at Screening Visit 2:
- Fasting serum LDL-C ≥70 mg/dL and <190 mg/dL using Friedewald equation.
- Fasting triglyceride <400 mg/dL.
Who cannot join
- Symptomatic orthostatic hypotension.
- Treatment with certain medications and/or unable to comply with prohibited medications requirements.
- Other protocol inclusion/exclusion criteria may apply
Trial locations and contacts
29 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Novartis Pharmaceuticals contact
29 sites in 1 country
United States29 sites, 29 recruiting
- Recruiting
Flourish Medical Clinical Trials
Boca Raton, Florida, 33434
Cassandra Duff, cduff@flourishresearch.com
Rasha Youssef
- Recruiting
Clinical Research of Brandon LLC
Brandon, Florida, 33511
Erika Santos, esantos@crofb.com
German Alvarez
- Recruiting
East Coast Research
Canton, Georgia, 30114
Marvelyn Brentum, marvelyn.brentum@roviaclinical.com
Jason Berner
- Recruiting
Great Lakes Clinical Trials
Chicago, Illinois, 60640
Megi Stafa, +1 773 275 3500, mstafa@flourishresearch.com
Manish Jain
- Recruiting
ALL Medical Research LLC
Cooper City, Florida, 33024
Alejandro Marin, +1 754 263 2001, amarin@allmedicalresearch.com
Lorena Lewy-Alterbaum
- Recruiting
AMR Miami
Coral Gables, Florida, 33134
Odalys Fundora, odalys.fundora@amr-clinical.com
Abid Chaudhry
- Recruiting
Universal Axon Clinical Research
Doral, Florida, 33166
Glenda Padron, glenda.padron@roviaclinical.com
Luis Martinez
- Recruiting
G and L Research LLC
Foley, Alabama, 36535
Christine S Fuller, glresearch5@gmail.com
Nidal Morrar
- Recruiting
Anderson Medical Research
Ft. Washington, Maryland, 20744
Ann-Marie Cobb, andersonmedicalresearch@gmail.com
Felton Anderson
- Recruiting
Synergy Group Medical LLC
Houston, Texas, 77061
Graciela Lopez, +1 281 206 0068, glopez@synergygroupus.com
Deirdre McMullen
- Recruiting
Synergy Group Medical LLC
Houston, Texas, 77061
Reina Romero, +1 832 532 4210, rromero@synergygroupus.com
Caroline N Mbogua
- Recruiting
East Coast Institute for Research
Jacksonville, Florida, 32216
Carol Tunsil, +1 386 868 5625, carol.tunsil@roviaclinical.com
Minesh Patel
- Recruiting
Capitol Cardiology Associates
Lanham, Maryland, 20706
Iluyomade Adeusi, +1 301 312 0575, iluyomade@capitolcardiology.com
Vineet Venugopal
- Recruiting
Clinical Trials Research
Lincoln, California, 95648
Stacy Woodward, +1 916 434 8230, stacy@ctrsites.com
Jeffrey D Wayne
- Recruiting
Walker Family Care
Little River, South Carolina, 29566
Madelyn Poore, mpoore@littlerivercr.com
Stephen D Grubb
- Recruiting
Downtown L A Research Center Inc
Los Angeles, California, 90017
Claudia Cisneros, +1 213 261 3680, ccisneros@dtlaresearch.com
Salil U Nadkarni
- Recruiting
Manassas Clinical Research Center
Manassas, Virginia, 20110
Arleth Lopez, +1 703 330 1112, arleth@manassasclinic.com
Nabil Andrawis
- Recruiting
Entrust Clinical Research
Miami, Florida, 33176
Daimelys Garcia, Dgarcia@entrustclinicalresearch.com
Adolfo Cueli
- Recruiting
Inpatient Research Clinical LLC
Miami Lakes, Florida, 33014
Ilianys Marino, +1 786 502 4303, imarino@inpatientresearch.com
Alexis Gutierrez
- Recruiting
Inpatient Research Clinical LLC
Miami Lakes, Florida, 33014
Enrique Pacheco, epacheco@inpatientresearch.com
Jose Contreras
- Recruiting
Monroe Biomedical Research
Monroe, North Carolina, 28112
Avrie Torres, +1 704 283 7359, atorres@onsiteclinical.com
Awawu Igbinadolor
- Recruiting
AMR Chicago
Niles, Illinois, 60714
Unnathi Nagelli, +1 630 491 1901, unnathi.nagelli@amr-clinical.com
Manohar Jethani
- Recruiting
Valley Clinical Trials
Northridge, California, 91325
Haydee Gutierrez, hgutierrez@flourishresearch.com
Mehrdad Ariani
- Recruiting
American Research Centers of FL
Pembroke Pines, Florida, 33027
Liliana Portal, lportal@americanresearchcenters.com
Luis Del Prado Rodriguez
- Recruiting
Dominion Medical Associates
Richmond, Virginia, 23219
Tara Snead, +1 804 836 6540, tara@dominionmedicalinc.com
Richard A Jackson
- Recruiting
East Coast Inst for Research LLC
Saint Augustine, Florida, 32086
Rebecca Fink, +1 904 824 1776#116, becca.fink@roviaclinical.com
Ferris George
- Recruiting
The Center for Clinical Trials
Saraland, Alabama, 36571
JoAnn Ladner, joann@thecenterforclinicaltrials.com
Howard Rubenstein
- Recruiting
Monroe Research Llc
West Monroe, Louisiana, 71291
Nina Parrott, ninaparrottlpncrc@monroeresearch.net
Assad Mouhaffel
- Recruiting
Alliance for Multispecialty Research
Wichita, Kansas, 67207
Shaunacie Mc Callum, shaunacie.mccallum@amr-clinical.com
Jerry Punch
About this study
Official title: A Multicenter, Randomized, Double-blind, Factorial Design Phase 2 Study to Evaluate the Pharmacodynamics, Safety and Tolerability of HDY015 Administered as a Free Combination of QCZ484 and Inclisiran Compared to QCZ484, Inclisiran, and Placebo in Participants With Hypertension and Concomitant Hypercholesterolemia
This is a multicenter, randomized, double-blind, factorial design Phase 2 study to evaluate the pharmacodynamics, safety and tolerability of a combination of QCZ484 and inclisiran compared to QCZ484, inclisiran, and placebo in participants with hypertension and concomitant hypercholesterolemia.
Read the detailed description
The study will last up to 12 months and has three periods:
- Eligibility will be assessed during the screening period including 2 screening visits. Some eligibility criteria will be confirmed at the Baseline/Randomization visit.
- Eligible participants will be randomized to receive a combination of QCZ484 and inclisiran, QCZ484, inclisiran or placebo once on Day 1 at the Baseline/Randomization visit.
- Afterwards, participants will enter the safety follow-up period. Eligible participants who complete the treatment period have the option to participate in an open-label extension study instead of entering the safety follow-up period.
- Conditions
- Hypercholesterolaemia
- Being tested
- QCZ484, Inclisiran, QCZ484 placebo, Inclisiran placebo
- Keywords
- Hypertension, hypercholesterolemia, siRNA, inclisiran, QCZ484, randomized, double-blind, Phase 2, pharmacodynamics, AGT, PCSK9
- Medical subject headings
- Hypercholesterolemia, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QCZ484Drug
QCZ484 once on Day 1
InclisiranDrug
Also called KJX839, Leqvio
Inclisiran once on Day 1
QCZ484 placeboDrug
QCZ484 placebo once on Day 1
Inclisiran placeboDrug
Inclisiran placebo once on Day 1
| Study group | Role | What they receive |
|---|---|---|
| QCZ484 + Inclisiran | Experimental | QCZ484 + inclisiran, once on Day 1 Receives: Drug: QCZ484; Drug: Inclisiran |
| QCZ484 | Active comparator | QCZ484 + inclisiran placebo, once on Day 1 Receives: Drug: QCZ484 |
| Inclisiran | Active comparator | Inclisiran + QCZ484 placebo, once on Day 1 Receives: Drug: Inclisiran |
| Placebo | Placebo comparator | QCZ484 placebo + inclisiran placebo, once on Day 1 Receives: Drug: QCZ484 placebo; Drug: Inclisiran placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change from baseline of PCSK9 levels
Percent (%) change from baseline of PCSK9 levels for QCZ484 + Inclisiran at Month 3
Measured: Baseline and Month 3
Percent change from baseline of AGT levels
Percent (%) change from baseline of AGT levels for QCZ484 + Inclisiran at Month 3
Measured: Baseline and Month 3
Secondary outcomes (3)
Change from baseline of systolic blood pressure
Change from baseline of systolic blood pressure for QCZ484 + Inclisiran at Month 3 and 6.
Measured: Baseline, Month 3 and Month 6
Change from baseline of LDL-C levels
Change from baseline of LDL-C levels for QCZ484 + Inclisiran at Month 3 and 6.
Measured: Baseline, Month 3 and Month 6
Number of participants with Treatment-emergent adverse event and abnormal changes in laboratory parameters, vital signs and other safety assessments
Number of participants with treatment-emergent adverse event, abnormal changes in laboratory parameters, vital signs and other safety assessments up to Month 12.
Measured: Up to month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2026
- Study start29 May 2026
- Primary completion28 Apr 2027 (estimated)
- Study completion3 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolaemiaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07610278
- Sponsor's protocol ID
- CHDY015A12201
- Status last verified
- Jul 2026
- First submitted
- 20 May 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on https://www.clinicalstudydatarequest.com/.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Factorial Design Phase 2 Study to Evaluate the Pharmacodynamics, Safety and Tolerability of HDY015 Administered as a Free Combination of QCZ484 and Inclisiran Compared to QCZ484, Inclisiran, and Placebo in Participants With Hypertension and Concomitant Hypercholesterolemia
- ClinicalTrials.gov ID
- NCT07610278
- Acronym / sponsor ID
- CHDY015A12201
- Conditions
- Hypercholesterolaemia
- Keywords
- Hypertension, hypercholesterolemia, siRNA, inclisiran, QCZ484, randomized, double-blind, Phase 2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 29 May 2026 (actual)
- Primary completion
- 28 Apr 2027 (estimated)
- Study completion
- 3 Feb 2028 (estimated)
- First posted
- 27 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, randomized, double-blind, factorial design Phase 2 study to evaluate the pharmacodynamics, safety and tolerability of a combination of QCZ484 and inclisiran compared to QCZ484, inclisiran, and placebo in participants with hypertension and concomitant hypercholesterolemia.
Detailed description
The study will last up to 12 months and has three periods:
- Eligibility will be assessed during the screening period including 2 screening visits. Some eligibility criteria will be confirmed at the Baseline/Randomization visit.
- Eligible participants will be randomized to receive a combination of QCZ484 and inclisiran, QCZ484, inclisiran or placebo once on Day 1 at the Baseline/Randomization visit.
- Afterwards, participants will enter the safety follow-up period. Eligible participants who complete the treatment period have the option to participate in an open-label extension study instead of entering the safety follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| QCZ484 + Inclisiran | Experimental | Drug: QCZ484, Drug: InclisiranQCZ484 + inclisiran, once on Day 1 |
| QCZ484 | Active comparator | Drug: QCZ484QCZ484 + inclisiran placebo, once on Day 1 |
| Inclisiran | Active comparator | Drug: InclisiranInclisiran + QCZ484 placebo, once on Day 1 |
| Placebo | Placebo comparator | Drug: QCZ484 placebo, Drug: Inclisiran placeboQCZ484 placebo + inclisiran placebo, once on Day 1 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Males or females aged 18 to 75 years.
- Diagnosis of primary hypertension.
- Treatment with either no, or up to 2 antihypertensive medications at a stable dose for at least 4 weeks preceding screening.
- Systolic blood pressure ≥140 and <165 mmHg based on the mean of 3 sitting measurements based on office blood pressure monitoring.
- Diagnosis of hypercholesterolemia including heterozygous familial hypercholesterolemia unable to reach LDL-C goals with a stable dose of statin treatment for at least 4 weeks prior to screening as per Investigator judgement, guidelines and local practice (if tolerated and not contraindicated) with or without bempedoic acid and with or without ezetimibe prescribed according to local guidance, at a stable dose for at least 4 weeks preceding Screening Visit 1.
Key exclusion criteria (3 listed)
- Symptomatic orthostatic hypotension.
- Treatment with certain medications and/or unable to comply with prohibited medications requirements.
- Other protocol inclusion/exclusion criteria may apply
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QCZ484QCZ484 once on Day 1 | Drug | QCZ484, QCZ484 + Inclisiran |
| InclisiranAlso: KJX839, LeqvioInclisiran once on Day 1 | Drug | Inclisiran, QCZ484 + Inclisiran |
| QCZ484 placeboQCZ484 placebo once on Day 1 | Drug | Placebo |
| Inclisiran placeboInclisiran placebo once on Day 1 | Drug | Placebo |
Primary outcome
Percent change from baseline of PCSK9 levels
Time frame: Baseline and Month 3
Percent (%) change from baseline of PCSK9 levels for QCZ484 + Inclisiran at Month 3
Percent change from baseline of AGT levels
Time frame: Baseline and Month 3
Percent (%) change from baseline of AGT levels for QCZ484 + Inclisiran at Month 3
3 secondary outcomes
Change from baseline of systolic blood pressure
Time frame: Baseline, Month 3 and Month 6
Change from baseline of LDL-C levels
Time frame: Baseline, Month 3 and Month 6
Number of participants with Treatment-emergent adverse event and abnormal changes in laboratory parameters, vital signs and other safety assessments
Time frame: Up to month 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Individual participant dataSharing planned: Yes. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on https://www.clinicalstudydatarequest.com/.
Related trials for Hypercholesterolaemia
Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
Active, not recruitingObservational study
Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
Familial Hypercholesterolaemia
Not yet recruiting
Penn Family Screening for Familial Hypercholesterolemia (NHLBI R33) Trial 3
Familial Hypercholesterolemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Novartis Pharmaceuticals contact
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing QCZ484 and Inclisiran in people with Hypercholesterolaemia, run by Novartis Pharmaceuticals at 29 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Novartis Pharmaceuticals (1-888-669-6682, novartis.email@novartis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent change from baseline of PCSK9 levels (time frame: Baseline and Month 3). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.